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oy, The Nin LL I SITY
5/ Rockefeller THE ROCKEFELLER UNIVERSIT
” University /< 1230 YORK AVENUE NEW YORK, NY 10021
O
o> a September 26, 1980

JOSHUA LEDERBERG

PRESIDENT

Dr. Marion Finkel

Associate Director for New

Drug Evaluation

Department of Health, Education
& Welfare

Food and Drug Administration
5600 Fishers Lane

Rockville, Maryland 20852

Dear Dr. Finkel:

It was a pleasure to have a chance to meet you at the
Hoechst Symposium the other day. I'm sorry that you had
to leave before we could continue a discussion on some of
the topics that you introduced. I am not sure whether you
have any more robust confidence than I in the adequacy of
our present procedures for assessing risks like cancer,
from animal experimentation as currently conducted. I feel
rather gloomy about being able to develop socially optimized
policies on regulation without a major intellectual recon-
struction of toxicology as a scientific discipline; and this
is not something that can be done overnight. Your plea that
the companies be more energetic and candid in forwarding
realistic risk-benefit analysis I did applaud. Meanwhile
the obvious contemporary deterrents to vigorous and optimis-—
tic investment in pharmaceutical research of the most funda-
mental kind is simply leading many companies to pursue their
profits by other routes -- and for the large ones this is not
an obvious hindrance to their balance sheets.

But your slide of the number of inputs that you receive
in the regulatory process is most impressive; and perhaps
only a fool now dares to tread on such a well worked-over
territory.

I was also intrigued by your reference to the discussion
about indications for elective induction of pregnancy, about
which I had heard only some vague rumor. Some years ago, I
was quite interested in births by day of week and wondered
Dr. Marion Finkel
September 26, 1980

-2-

a) if I could find statistics on the frequency with which
elective induction was practiced that could hope to ac-
count for the "Sunday effect"; b) whether there were other
endogenous psychosomatic factors involved in the regula-
tion of delivery time and c) whether there might be ad-
verse effects on pregnancy outcome by the practice of
elective induction. The latter is, of course, confounded
by the fact that there will sometimes be specific medical
indications for this practice that are bound to lead to
some complications in that group. My recollection is a
little fuzzy now about what further was done about this:

I believe I had some conversations about using the NINDS
perinatal morbidity study but to my present recollection
nothing came out ‘of it. If you can give me some pointers
back into the mainstream of that discussion I would be ap-
preciative of it.

I hope there may be some occasion for a more leisurely
discussion of a number of subjects in which I am sure we
share a deep mutual interest.

Yours sincerely,

yoo Lederberg

Encls. .